Study of the CAT RX Aspiration Catheter When Used in Patients With Large Occlusive Thrombus in Coronary Arteries

Penumbra

Status: Completed

Conditions: Coronary Vessel Occlusion

Treatments: Device: Indigo Aspiration System

Study type: Observational

Funder types: Industry

Identifiers

NCT03957473

CLP 15298

Details and patient eligibility

About

The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI).

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age ≥ 18 years
• Patient presents to treating facility within 12 hours of symptom onset
• High thrombus burden at coronary angiography, defined as TIMI thrombus grade 4 or 5 by physician visual estimate after the guidewire crosses the target lesion
• Frontline treatment with the Indigo® Aspiration System using the CAT RX Aspiration Catheter, prior to standard of care PCI
• Target lesion is located in a native coronary artery
• Informed consent is obtained from either patient or legally authorized representative (LAR)

Exclusion criteria

• New onset of stroke symptoms and NIHSS > 2, prior to index procedure
• Treatment with fibrinolytic therapy for index coronary vessel occlusion
• Life expectancy less than 6 months due to any comorbidities
• Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
• Participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
• Patient is pregnant

Trial design

400 participants in 1 patient group

Single Arm

Description:

Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions

Treatment:

Device: Indigo Aspiration System